1. U.S. Food and Drug Administration. FDA report. Final report of pharmaceutical cGMPs for the 21st Century–a risk-based approach. Silver Spring, MD: FDA; 2004.
2. U.S. Food and Drug Administration. FDA White Paper. Question-based review (QbR) for generic drugs: an enhanced pharmaceutical quality assessment system. Silver Spring, MD: FDA; 2005.
3. U.S. Food and Drug Administration. FDA Report. Implementation of Quality by Design (QbD): Status, Challenges and Next Steps. Silver Spring, MD: FDA; 2006
4. U.S. Food and Drug Administration. FDA Policy & Procedures. Applying ICH Q8(R2), Q9, and Q10 Principles to Chemistry, Manufacturing, and Controls Review. MAPP 5016.1. Silver Spring, MD: FDA; 2016. Available at: https://www.fda.gov/downloads/AboutFD/UCM242665.pdf. Accessed January 2, 2018.
5. Materials science tetrahedron—a useful tool for pharmaceutical research and development;Sun;J Pharm Sci,2009